Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class I · High risk
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Kit for the Preparation of Technetium TC-99M Mebrofenin
Failed Stability Specifications
Class III · Low risk
Ferrous Sulfate 325 MG tablet
Presence of Foreign Tablets/Capsules
Class III · Low risk
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for adhesive transfer.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class II · Moderate risk
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.